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The Role of Chest Electrical Impedance Tomography in the Pediatric Ventilator Weaning

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04011852
Recruitment Status : Recruiting
First Posted : July 9, 2019
Last Update Posted : September 26, 2019
Sponsor:
Information provided by (Responsible Party):
University of Sao Paulo General Hospital

Brief Summary:

To correlate the data obtained by Electrical impedance tomography (EIT) during the spontaneous breathing trials (SBT) on a T-piece, in children, with failure in the trial and Extubation failure.

Observe if the EIT monitoring will be able to detect the children that will fail earlier than the SBT performed alone.

Method: A cross-sectional, prospective study to explore the potential benefits of monitoring with EIT during weaning.


Condition or disease Intervention/treatment
Ventilator Weaning Child Spontaneous Breathing Trial Electrical Impedance Tomography Device: Electrical Impedance tomography

Detailed Description:
Early and successful Extubation is sometimes a difficult combination in children, since the criteria for suggesting it are often subjective and poorly defined. Electrical impedance tomography (EIT) has been developed and used clinically for more than 30 years. Interest in this technology arose from the need to monitor ventilation and pulmonary perfusion at the bedside. Because it is a non-invasive and non-radiation technology, EIT is very promising in the pediatric population. Objectives: To correlate the data obtained by the EIT during the spontaneous breathing trials (SBT) on a T-piece with failure in the trial and Extubation failure and to observe if the EIT is able to detect the children that will fail earlier than the SBT performed alone. Method: A cross-sectional, prospective study to explore the potential benefits of monitoring with EIT during weaning. Qualitative characteristics will be described using absolute and relative frequencies and the quantitative characteristics will be described using summary measures (mean, standard deviation, median, minimum and maximum). Bivariate and later multiple logistic regression analyzes will be performed to evaluate the influence of characteristics assessed on weaning failure, mainly the reduction in functional residual capacity during and after the weaning trial. For the analysis will be used the software IBM-SPSS for Windows version 20.0 and tabulation of the data will be used Microsoft Excel 2010 software. The tests will be performed with significance level of 5%.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 134 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 2 Years
Official Title: The Role of Chest Electrical Impedance Tomography in the Pediatric Ventilator Weaning
Estimated Study Start Date : September 24, 2019
Estimated Primary Completion Date : September 4, 2020
Estimated Study Completion Date : September 4, 2021

Intervention Details:
  • Device: Electrical Impedance tomography
    Monitoring with Electrical impedance tomography during spontaneous breathing trials on T-piece in children


Primary Outcome Measures :
  1. Correlate Electrical impedance tomography to Extubation failure [ Time Frame: 48 hours ]
    Compare data obtained by the EIT during the spontaneous breathing trial with Extubation failure

  2. Correlate Electrical impedance tomography to spontaneous breathing trial failure [ Time Frame: 1 hour ]
    Observe if Electrical impedance tomography detects children who will fail in spontaneous breathing trial (during a 1-hour T-piece) earlier than clinical criteria


Secondary Outcome Measures :
  1. Electrical impedance tomography Security [ Time Frame: 2 hours ]

    Evaluate Electrical impedance tomography Security (skin lesion or pain)

    Neonatal Skin Condition Score

    Dryness

    1. Normal, no sign of dry skin
    2. Dry skin, visible scaling
    3. Very dry skin, cracking/fissures

    Erythema

    1. No evidence of erythema
    2. Visible erythema, < 50% body surface
    3. Visible erythema, ≥ 50% body surface

    Breakdown

    1. None evident
    2. Small, localized areas
    3. Extensive

    Note:

    Perfect score = 3 Worst score = 9


  2. Compare tidal volume and RR / VT index with Z-delta and RR / Z-delta [ Time Frame: 1 hour ]
    Verify whether traditional measures of tidal volume and the RR / VT index can be independently and accurately assessed through the measurement of Z-delta and RR / Z-delta, through the Electrical impedance tomography.



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Ages Eligible for Study:   up to 15 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Children who are on mechanical ventilation for a period of more than 24 hours, between 28 days of age and 15 years, who are admitted to the pediatric intensive care unit (ICU) of the Children's Institute in Brazil and are ready for a weaning trial.
Criteria

Inclusion Criteria:

Children who are on mechanical ventilation for a period of more than 24 hours, between 28 days of age and 15 years, who are admitted to the pediatric intensive care unit (ICU) of the Children's Institute in Brazil

Exclusion Criteria:

  • Upper Airway Obstruction
  • Diaphragmatic hernia or diaphragmatic paralysis
  • Chronic use of mechanical ventilation
  • Cyanogenic congenital heart disease
  • Primary pulmonary hypertension
  • Neuromuscular disease
  • Tracheostomy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04011852


Contacts
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Contact: Flávia K Foronda, MD PhD +5511994440536 flikrepel@foronda.com.br
Contact: Leonardo R Fernandes, MD +5511951164242

Locations
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Brazil
University of São Paulo General Hospital Recruiting
São Paulo, Sao Paulo, Brazil
Contact: Flavia Andrea K Foronda, MD PhD    5511994440536    flikrepel@foronda.com.br   
Contact: Leonardo Fernandes    5511951164242      
Sponsors and Collaborators
University of Sao Paulo General Hospital
Investigators
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Principal Investigator: Flávia K Foronda, MDPhD Full staff
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Responsible Party: University of Sao Paulo General Hospital
ClinicalTrials.gov Identifier: NCT04011852    
Other Study ID Numbers: 10055719.0.0000.0068
First Posted: July 9, 2019    Key Record Dates
Last Update Posted: September 26, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Sao Paulo General Hospital:
Ventilator Weaning
Child
Electrical Impedance Tomography
Respiration, artificial
Intensive Care units
Additional relevant MeSH terms:
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Respiratory Aspiration
Respiration Disorders
Respiratory Tract Diseases
Pathologic Processes